Acute Kidney Injury in Neonates

This study has been withdrawn prior to enrollment.
(Investigator's decision:Did not open to enrollment)
Sponsor:
Information provided by:
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00572715
First received: December 11, 2007
Last updated: February 8, 2010
Last verified: February 2010
  Purpose

Our first aim is to describe how common a sudden decrease in renal function happens in infants in a neonatal intensive care unit. We also want to see how a sudden loss of renal function affects survival. Finally, we will explore non-invasive markers to identify a sudden decrease in renal function from urinary samples.


Condition
Acute Kidney Injury

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Acute Kidney Injury in Neonates

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Characterize the incidence and risk factors of AKI in critically ill neonates [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare Hospital outcomes of critically ill neonates with and without AKI. Test the ability of known noninvasive urinary biomarkers ability to detect AKI in neonates [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: January 2010
Estimated Study Completion Date: January 2010
Groups/Cohorts
Observation

Inclusion criteria - Families of infants (birthweight >1500g) be asked to participate in the study.

Exclusion criteria - Infants with prenatal renal ultrasound diagnosis of severe hydronephrosis or other known renal abnormalities will be excluded


Detailed Description:

Advancements in the field of peri-natal medicine has improved the survival of critically ill neonates but yet many still do not survive, and many more are left with long-term damage to vital organ systems. Very little data is available on the impact that acute kidney injury (AKI) has on survival in term neonates, but adult and pediatric studies that show that even mild AKI independently impacts survival after correcting for severity of illness. The role that AKI impacts survival in neonates is likely to be greater than adults as this acute injury occurs in context of impaired and ongoing kidney development.

Our ability to improve outcomes in children and adults with AKI has been hampered by the inability to recognize AKI early in the disease process. Thus, the work on early non-invasive biomarkers of renal injury has brought great optimism to the field of AKI. Serum and urinary levels of neutrophil gelatinase-associated lipocalin (NGAL), urinary interleukin 18 (IL-18) others are markedly elevated several hours after AKI as opposed to serum creatinine which takes days to rise after the inciting event. Early non-invasive biomarkers of AKI have not been tested in neonates.

Inclusion criteria - Families of infants (birthweight >1500g) be asked to participate in the study.

Exclusion criteria - Infants with prenatal renal ultrasound diagnosis of severe hydronephrosis or other known renal abnormalities will be excluded

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Inclusion criteria - Families of infants (birthweight >1500g) be asked to participate in the study.

Exclusion criteria - Infants with prenatal renal ultrasound diagnosis of severe hydronephrosis or other known renal abnormalities will be excluded

Criteria

Inclusion Criteria:

  • Families of infants (birthweight >1500g) be asked to participate in the study.

Exclusion Criteria:

  • Infants with prenatal renal ultrasound diagnosis of severe hydronephrosis or other known renal abnormalities will be excluded
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00572715

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: David Askenazi, MD University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: David Askenazi,Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00572715     History of Changes
Other Study ID Numbers: X070927001
Study First Received: December 11, 2007
Last Updated: February 8, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
kidney
neonates

Additional relevant MeSH terms:
Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 16, 2014